Industry Perspective on the FDA Guidance on Multiplicity Issues

• Activity Number: 645
• Type: Invited
• Date/Time: Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Walter W. Offen*+
• Companies: Eli Lilly and Company
• Keywords: multiplicity ; FDA Guidance ; clinical trials

Abstract

There are numerous multiplicity issues in clinical research that need to be addressed at the protocol design stage. These issues relate to both efficacy and safety analyses. They pertain, for example, to interim analyses, multiple dose groups, multiple endpoints (primary or secondary), and subgroup analyses leading to tailored therapy indications and claims. Multiplicity issues are also very prevalent in so-called "substantial evidence" required by FDA DDMAC in order to allow promotion based on the findings. This talk will present an overview of all of these issues with proposed solutions, and will focus the majority of the discussion on key areas of the FDA Guidance that are potentially controversial or complex. The FDA draft guidance is not expected to become available until shortly before this session. Hence the specific key multiplicity topics will be identified later.